US20070270890A1 - System and Method for Treating Tissue Wall Prolapse - Google Patents

Abstract

The invention disclosed herein includes an apparatus and a method for treatment of vaginal prolapse conditions. The apparatus is a graft having a central body portion with at least one strap extending from it. The strap has a bullet needle attached to its end portion and is anchorable to anchoring tissue in the body of a patient. The invention makes use of a delivery device adapted to deploy the graft in a patient. The inventive method includes the steps of making an incision in the vaginal wall of a patient, opening the incision to gain access inside the vagina and pelvic floor area, inserting the inventive apparatus through the incision, and attaching the straps of the apparatus to anchoring tissue in the patient.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS
• This application claims priority from U.S. Provisional Patent Application Ser. No. 60/782,911, filed on Mar. 16, 2006, and U.S. Provisional Patent Application Ser. No. 60/852,932, filed Oct. 19, 2006, both of which are expressly incorporated herein by reference in their entirety.
BACKGROUND OF THE INVENTION
• 1. Field of the Invention
• The present invention relates in general to a system and method in the field of prolapse treatment. More particularly, the present invention relates to an apparatus with multiple components, and a method for surgically correcting tissue wall prolapse using the same. Specifically, one embodiment of the present invention is a kit that has a pre-cut shaped mesh graft, and a graft delivery device.
• 2. Discussion of the Related Art
• As is known to those skilled in the art, the treatment of vaginal wall prolapse has been hampered by high failure rates. Reasons for failure include the inherent weakness of the tissue being re-approximated and the inability of the repair to withstand the forces applied by the abdominal cavity bearing down from above. In the last decade, one advance in repair has been the addition of grafts to reinforce vaginal prolapse repairs. While this technique has gained acceptance, there lacks a consensus regarding how to affix the graft under the vaginal wall to best maintain durability and vaginal caliber.
• Some known procedures can cause patient discomfort and/or pain and there is a risk that the graft will become dislodged with time. Additionally, when a graft is sewn into place with standard sutures over the pelvic floor muscles, it may cause pain from suture entrapment. Further, sutures are prone to pullout because the sutures are placed into tissue that is thin and inherently weak. Finally, the placement of the sutures varies among surgeons. Accordingly, it is difficult to teach proper graft placement.
• With the introduction of new techniques, improved devices have been made commercially available. In general, these systems utilize medical mesh with wings at the corners so that the mesh may be drawn through the pelvic floor musculature and pelvic ligaments to secure the mesh.
• An accepted access point for securing the wings of these systems has been through the obturator membrane and ischiorectal fossa. Access is generally made via these structures because the apex of the vagina is located deep within the pelvis. However, the problem with accessing the apex via these structures is that this anatomy is unfamiliar to surgeons. Further, safety remains a concern for surgeons because these systems require the passage of sharp needles long distances through these unfamiliar anatomic paths with unseen neurovascular structures potentially nearby. Thus, extensive training and anatomy education is required to properly learn the technique.
• In general, the embodiments disclosed in the above-referenced patents and publications have the disadvantage that they are difficult or dangerous to use without extensive training. Also, they are only partially effective to treat prolapse. Other disadvantages include increased risk and ineffective results over time. Given these disadvantages, patients suffering prolapse either must wait long periods of time for treatment or forego treatment altogether because of the risk involved and the necessary high-level of surgeon skill. This further leads to a procedure with a relatively high cost.
• Therefore, what is needed is a relatively simple apparatus and method for the treatment of vaginal wall prolapse. Specifically, what is needed is an apparatus and method that reduce patient discomfort and that are easily repeatable and highly effective over time.
SUMMARY OF THE INVENTION
• The invention disclosed herein includes an apparatus and a method for treatment of vaginal prolapse conditions. The apparatus is a graft having a central body portion with at least one strap extending therefrom. The strap has a bullet needle attached to its end portion and is anchorable to anchoring tissue in the body of a patient. The invention makes use of a delivery device adapted to deploy the graft in a patient. The inventive method includes the steps of making an incision in the vaginal wall of a patient, opening the incision to gain access inside the vagina and pelvic floor area, inserting the inventive apparatus through the incision, and attaching the straps of the apparatus to anchoring tissue in the patient.
BRIEF DESCRIPTION OF THE DRAWINGS
• FIG. 1 illustrates a top view of a graft according to an embodiment of the present invention.
• FIGS. 2a,2b,and2cillustrate top views of various wings and bullet needles of the graft according to an embodiment the present invention.
• FIGS. 3aand3billustrate a side cut away view of a graft placement device.
• FIGS. 4aand4bare cut-away views of a portion of the graft placement device ofFIG. 3a.
• FIGS. 5a,5b,5c,and5dillustrate a side view of a portion of the graft placement device ofFIG. 3aand a bullet needle.
• FIG. 6 illustrates a side cut-away view of a portion of the graft placement device ofFIG. 3a.
• FIGS. 7a,7b,7cand7dare schematic illustrations of a vaginal area of a patient.
• FIG. 8 is a schematic illustration of various parts of the female anatomy with some components of the present invention in place.
• In describing the illustrated embodiments of the invention that is illustrated in the drawings, specific terminology may be used for the sake of clarity. However, it is not intended that the invention be limited to the specific terms so selected and it is to be understood that each specific term includes all technical equivalents that operate in a similar manner to accomplish a similar purpose.
DETAILED DESCRIPTION
• This invention, which includes elements of a method and device, represents a novel way of treating vaginal wall prolapse. The present invention overcomes the above-mentioned limitations of the art. The invention has two main components: a graft and a graft placement device or delivery device. The graft itself can have several sizes and shapes and be made of a variety of materials. See, e.g., U.S. Pat. Nos. 6,102,921 and 6,638,284 incorporated in their entirety by reference. In one embodiment, a synthetic polypropylene mesh graft version is used. One embodiment of the inventive graft is designed to cover the entire vaginal vault and provide anchoring to the arcus tendineus, the sacrospinous ligament, and/or the levator ani muscle of the patient.
• Whereas several known methods use long needles to aid in graft placement (which hamper their adoption), the disclosed apparatus uses a graft that includes bullet needles attached thereto. The bullet needles are configured to attach the graft to the accepted anatomic structures without having to pass through the previously mentioned unfamiliar pathways such as the ischiorectal fossa or the obturator membrane. The graft is, therefore, able to, as a result of its design, reach the desired attachment points directly through the vaginal canal.
• The graft may be placed using a placement device or delivery device. One embodiment of the delivery device is a device such as a Boston Scientific Corporation “Laurus” or “Capio” device, which can be good a predicate device for the delivery device component of this kit. The graft delivery device acts as a suture-capturing device also but in the disclosed invention the suture can be a mesh wing, such as a strap, arm, or leg.
• Using the components described above, in one embodiment, the inventive method includes the following steps: making an incision in the vaginal wall; opening the incision to gain access inside the vagina and Pelvic Floor; taking a suture-capturing device in hand; attaching a mesh wing with a bullet needle to a suture capturing device; inserting the wing, needle and suture device through the incision and inside the vagina; pushing the wing and bullet needle through the ligaments or muscle; pulling the wing back out of the incision with the suture device; releasing the bullet needle and wing from the suture device; attaching another wing and its bullet needle to the suture capturing device, and repeating the process at another location within or through the vagina; repeating the process with the other wings and bullet needles until all of the wings are attached to the commonly accepted apical and lateral support structures. These are generally the sacrospinous ligament, proximal arcus tendineus, and levator ani muscle. This wing securement allows the custom adjustment for each patient, which would not occur with conventional suture fixation. The excess mesh wing material should then be trimmed away and discarded. After the remaining mesh is secured, the incision is closed.
• As mentioned above, one embodiment of the present invention has two main components. The first component is a graft. As best shown inFIG. 1, in one embodiment the graft has a unique shape. While thegraft22 can be shaped as shown inFIG. 1, the graft may be of any suitable shape and generally will incorporate a central body portion and at least two longitudinal side portions, e.g., arms. For example, the graft of the present invention may be produced in a substantially oval shape or trapezium shape with extension arms and legs extending away from the central body portion of the graft. The graft can be positioned over the pubocervical fascia and secured via the surrounding ligaments and/or muscles.
• In the embodiment illustrated inFIG. 1, thegraft22 has protrusions referred to as arms, legs, and wings (or generally “wings”). Theinventive graft22 includes anupper portion23,first edge24,first wing25a,second wing25b,third wing26a,andfourth wing26b.Acentral body portion27, afirst arm27a,and asecond arm27balso make up thegraft22. Thegraft22 further includes alower portion29, afirst leg29a, asecond leg29b, a third connectingsegment29c, a fourth connectingsegment29d,and atail29e.In one embodiment, the mesh does not includewings25aand25b.
• The inventive wings, legs, and arms are intended to be used for attachment via the arcus tendineus near the ischial spine for the anterior vaginal wall, the sacrospinous ligament on the posterior vaginal wall, and/or the levator ani muscle. These anatomical structures are deep in the pelvis making them excellent for support but otherwise difficult to access without a graft delivery device as will be described more fully below. Once such a device reaches the preferred location, the device helps the surgeon to wedge the graft into place.
• In some embodiments, the graft material itself is similar to the mesh material made by Boston Scientific Corporation called “POLYFORM.” In other embodiments, a mesh as described in U.S. Patent Application Pub. No. 2005/0261545 or a mesh as described in U.S. Patent Application Pub. No. 2005/0222591, both of which are incorporated by reference in their entirety, is used as the material for the graft. There are also many types of available mesh grafts such as the mesh described in PCT/US 02/31681 to Ethicon, which is also incorporated by reference. One embodiment of a mesh includes a plurality of open pores bounded by strands made of nonwoven polymeric material, for example, a polypropylene having monofilament fibers, wherein the junctions between the strands are without open interstices and the majority of open pores of the mesh have an area of less than 15 mm². In some embodiments, the pore size has an area of less than 10 mm². In other embodiments, the pore size of the central body portion of the mesh is greater than the pore size of the longitudinal side portions. In some embodiments, the pore size range in these portions is between 3 mm and 8 mm wide. A mesh according to one embodiment of the invention is also light and very flexible having a weight of less than 0.0080 g cm². The materials and mesh arrangement are such so as to minimize the chance of infection after implantation.
• While any conventional prosthetic material currently used for the treatment of pelvic organ prolapse can be employed when performing the inventive method, there are many so-called biografts that can be used as well such as animal or human donor tissue or any other xenograft material such as pig dermis, bovine dermis, allograft, or homograft of skin. It is important to note that this novel system and method does not preclude using any number of materials as the graft and will be amenable to the use of future materials as they become available. However, while any of the above-mentioned materials are suitable for reinforcing the vaginal wall according to the disclosed method and with the disclosed apparatus, a synthetic polypropylene mesh is preferred.
• On each arm and leg, respectively, is afirst bullet needle28a,second bullet needle28b,third bullet needle28c,andfourth bullet needle28d.In one embodiment, thegraft22 also includes a first needle-connectingsegment26cand a second needle-connectingsegment26d.
• FIGS. 2a-2cshow various embodiments of the bullet needle and the leg or arm. InFIG. 2a, for example, thebullet needle28ais relatively small and generally round and is connected to thearm26avia a thread or very thin segment of mesh, e.g., by needle-connectingsegment26c. InFIG. 2b, thebullet needle128ais bigger (than28a) and is round and is connected to thearm126avia a segment of mesh. InFIG. 2c, for example, thebullet needle228ais bigger and flatter (than28aand128a) and is connected to thearm226avia a wider segment of mesh. In one embodiment, the bullet needles maybe formed from stainless steel. In another embodiment, the “needle” is formed of the graft material. For example the “needle” could be formed of more dense graft material. In such an embodiment, the stainless steel needles may be replaced altogether.
• While in some embodiments the inventive wing, leg, or arm of the graft is affixed to a relatively small rounded bullet needle, in some embodiments the wing, leg, or arm is also tapered to allow atraumatic passage of it through the tissue and promote gripping of the wider portion of the arm or leg to the surrounding tissue. Further, instead of using the needle method for attaching the graft, it is also possible for the graft to be attached by other fastening means. Such fastening means including a medical adhesive or glue, microwave or radio frequency welding, staples, tacks, and a hook and loop type fastener.
• One of the novel concepts in the disclosed invention is the adaptation of a previously-patented suture-passing device for the graft delivery device, e.g., as described in U.S. Pat. Nos. 5,364,408; 5,540,704; 5,458,609; 5,575,800, and 5,662,664 all incorporated by reference in their entirety. See also, e.g., U.S. Pat. Application Publication No. 2006/0052801, also incorporated in its entirety by reference. In one embodiment, the disclosed delivery device is based in part on the “Capio” device, which is sold by Boston Scientific Corp. The Capio device was originally patented as the Laurus device and is generally used elsewhere for suture passage in limited access cavities. An embodiment of the device is a trocar capped by a curvilinear needle guide and deployable bullet needle that passes to a catch mechanism. A plunger at the other end of the device deploys it.
• The disclosed graft can be placed using such a graft delivery device, such as the graft placement device as shown inFIGS. 3a-6, which is the second component of the inventive apparatus. The modification of such a graft placement device allows the surgeon to use this device to pass the graft's wings, e.g., the arms and legs, directly through the desired anchoring structures without having to traverse these pathways. Further, the disclosed graft placement device itself is easier to use than the graft delivery devices currently in use in prolapse surgery. Therefore, the disclosed graft placement device requires less skill to deliver the graft wings to their target locations.
• Detailed drawings of an illustrative embodiment of the graft delivery device are shown inFIGS. 3a,3b,4a,4b,5a-5d, andFIG. 6 wherein thegraft delivery device30 includes anouter housing32, with finger grips34aand34b, and adeployment catch36. In some embodiments, theouter housing32 is made of injection molded plastic such as polycarbonate, as are many other of the components described herein. Adeployment sleeve38, slidably disposed within theouter housing32, has aretention catch40 and is attached to apushrod42, constructed for example, of stainless steel. Adriver shaft44 includes abutton46 and has a hole48a, into which is bonded an elongaterigid shaft50a. Therigid shaft50a, which may be made of music wire, passes throughouter housing ribs52a,52b, and52c, and terminates slidably disposed within ahollow cylinder54a. Thehollow cylinders54aand54b, which can be made from stainless hypodermic tubing, are held in recesses in theouter housing ribs52band52c. An elongate flexible tubular member56a, that may be made of polypropylene or other suitable material, is also slidably disposed within thehollow cylinder54a. As shown inFIG. 4b, needle guide58amay also be constructed from stainless hypodermic tubing, and has pivot pins60aand60bpivotally disposed withinouter housing bosses62aand62b. A driving link64ais attached by alink pin66 to thepushrod42 and to the needle guide58aby apivot pin68a, with the entire mechanism preferably made of stainless steel so as to maximize the biocompatibility as well as the strength of the actuating members.
• Referring again toFIGS. 3aand3b, thedevice30 has adriver retainer70 that is slidably disposed within theouter housing32, and is fixably attached torigid shafts50aand50b, with ahole72 to allow thepushrod42 to pass slidably therethrough. Adriver spring74, which can be wound from stainless steel wire, is compressed between thedriver retainer70 and theouter housing rib52b. Adeployment spring76, also made of stainless steel wire is compressed between anend77 of thedeployment sleeve38 andouter housing rib52a. Aneedle catch78ais housed within a recess80ain theouter housing32. Referring now toFIG. 4b, a retraction line82athat is preferably made of Kevlar, is slidably threaded through the flexible tubular member56aand is attached to a needle carrier84aby means of a crimp86aor other means that would bind the retraction line82ato the needle carrier84a. The distal end of the retraction line82ais attached to therigid shaft50aby means of anothercrimp98aor other means.
• Referring toFIG. 3b,arm124 ofdeployment sleeve38 is pushed so that the sleeve slides within theouter housing32, compressingspring76, and inturn sliding pushrod42. As illustrated inFIG. 4b, when thepushrod42 slides relative to theouter housing32, it forces the needle guide58ato pivot about the pin60athat is retained inouter housing boss62a.
• Referring again toFIG. 4b, a retraction line82athat is preferably made of Kevlar, is slidably threaded through the flexible tubular member56aand is attached to a needle carrier84aby means of a crimp86aor other means that would bind the retraction line82ato the needle carrier84a. The distal end of the retraction line82ais attached to therigid shaft50aby means of anothercrimp98aor other means. The needle carrier84ais slidably disposed within the needle guide58a, and holds aneedle88a(ore.g. bullet needle28a), typically constructed of surgical grade stainless steel in arecess90a, such needle having asuture92aattached thereto. The suture material is preferably polyglycolic acid, but may be made of polypropylene, nylon, silk, catgut, or any other materials known in the art selected for its biocompatibility and tensile strength to be used in the body for the approximation of tissue. Thesuture92aexits the needle guide58aby means of a groove and is stored in arecess96 inouter housing32. In one preferred embodiment, suture92awould be, e.g.,thread26cwhich is connected to arm26aas shown inFIG. 2a.
• It should be understood that in the interest of clarity only one half of an embodiment of a graft placement device of the present invention is shown inFIGS. 5a,5b,5c,5d,and6. The other half is quite similar in function and structure to the half described herein. The upper portion of the device is similar in construction and materials to the previously disclosed embodiments, and is not repeated here. Thegraft placement device196 includes anouter housing198 havingbosses200 into which apin202 is rotatably inserted. Thepin202 is secured to anarm204, which is attached to aneedle carrier206. Apin208 onneedle carrier206 is rotatably inserted into ahole210 in alink212. Anotherpin214 is secured to apushrod216 and is rotatably inserted into anotherhole218 in thelink212. Thepushrod216 is attached to asleeve220 slidably disposed within theouter housing198.FIG. 6 shows a detail view of a needle222 (similar tobullet needle28a) held in arecess224 in theneedle carrier206. Athread226, likethread26c, is attached to theneedle222 and is threaded through aslot228 in theneedle carrier206. In some embodiments all components in this mechanism are constructed of surgical grade stainless steel, chosen for its biocompatibility and strength.
• In Use
• Using the components briefly described above, a placement method includes the following steps: making an incision in the vaginal wall; opening the incision to gain access inside the vagina and Pelvic Floor; taking a suture-capturing device, such as a graft placement device, in hand; attaching the mesh wing with bullet needle to the suture capturing device, such as a graft placement device; inserting the wing, needle and suture device through the incision and inside the vagina; pushing the wing and bullet needle through the ligaments or muscles; pulling the wing back out of the incision with the suture device; releasing the bullet needle and wing from the suture device; attaching another wing and its bullet needle to the suture device and repeating the process at another location within the vagina; repeating the process with the other wings and bullet needles until all of the wings are attached to some internal structure such as the commonly accepted apical and lateral support structures. These support structures are generally the sacrospinous ligament, the proximal arcus tendineus, and the levator ani muscle. This wing securement allows the custom adjustment for each patient, which would not occur with conventional suture fixation; the wings should then be tightened as necessary so that the graft control body is covering the internal top wall of the vagina. The excess mesh wing material should then be trimmed away and discarded. After the remaining mesh is secured, the vaginal incision is closed.
• Use and operation of the disclosed graft placement device will now be described beginning with reference toFIG. 5a. Thedevice196 is introduced into the abdomen.Sleeve220 slides within thehousing198 in the direction indicated by the arrow. As shown inFIG. 5b, as thesleeve220 moves, it pushes thepushrod216 which causes thelink212 to cause theneedle carrier206, along with theneedle222 and thethread226, to rotate about the axis defined by thepin202. Referring toFIG. 5c, it may be seen that theneedle222 is driven into acatch230 through anopening232 in theouter housing198. Accordingly, in reference toFIG. 5d,it is seen that as thepushrod216 is retracted, thelink212 is also retracted, causing theneedle carrier206 to rotate about thepivot pin202 and back through theopening232 into theouter housing198, the same position as shown inFIG. 5a.
• An alternative embodiment mesh delivery device may resemble the device disclosed in U.S. Pat. No. 6,936,952, which is incorporated by reference. As mentioned above, there are specific anatomic structures, deep in the pelvis, typically used for graft fixation, which are chosen due to their advantageous location and resistance to displacement. Nevertheless because these structures are difficult to access, an incision must be made in the vaginal wall. See, e.g.,FIGS. 7aand7b.Once the incision is made, a delivery device such as a graft placement device is used to put a graft in place. The placement device uses a needle, that can be affixed to each one of the mesh arms or legs of the implant. The needle and graft are loaded into a needle guide located on the delivery device. In some embodiments of the inventive method, once the graft and the needle are loaded in the graft placement device, the remainder of the body of the graft with the remaining arms and legs hangs from the needle. After the appropriate dissection of the paravaginal tissue is made and the anchoring structures are located and cleared of any connective tissue, the graft placement device is moved into place over the desired structure. The plunger is then compressed and the needle deployed. Once the needle and mesh pass through the desired anchoring structure, the entire device is gently retracted out of the vagina. This leaves the arm or leg of the graft loosely encircling the anchoring point. The delivery device is then again held in position to engage the subsequent needles from each of the remaining needles passing each wing around its respective anchoring point. The graft can be delivered as a single piece or cut into two separate pieces for delivery into the anterior and posterior wall of the vagina separately. The arm or leg can then be adjusted. This is done by pulling the graft as cephalad as necessary causing the graft to lie flat in its respective compartment. The ends of each arm or leg are then cut to release the needle. The excess mesh and needle are then disposed of.
• Turning toFIG. 7a,posteriorvaginal wall213 is shown with theepithelium214 of the posterior vaginal wall in place. In one embodiment of the inventive method, a longitudinal incision is performed in order to mobilize theepithelium214 off theunderlying fascia215. Dissection is carried out laterally to the levator ani muscles on each side. In the upper part of the vagina, dissection is continued in a lateral and cranial direction through the rectal pillars on both sides towards the sacrospinous ligaments on each side. This creates a safe space through which to deploy the device, and forms bilateral tunnels from the posterior vaginal wall dissection to each sacrospinous ligament. The fascia of the recto-vaginal septum can be plicated (not shown). As illustrated inFIG. 7c,a graft,e.g. graft216 designed for a posterior vaginal wall repair is placed over the recto-vaginal septum fascia215 with eachextension arm217,218 placed into the tunnel extending from the posterior vaginal wall dissection to the sacrospinous ligament. After the remaining mesh is secured, the vaginal incision is closed, as illustrated inFIG. 7d.The positioning of thegraft216 is depicted inFIG. 8, which shows its location relative to thesacrospinous ligament233, therectum234 and the vagina235. In other embodiments, similar methods can be used to access and attach the graft to the levator ani muscle.
• The device and method described here can also be implemented with other modifications that allow it to be performed in conjunction with other procedures such as uterine preservation procedures.
• While the preferred embodiments and best modes of utilizing the present invention have been disclosed above, other variations are also possible. For example, the materials, shape and size of the components may be changed. Various alternatives are contemplated as being within the scope of the following claims that particularly point out and distinctly claim the subject matter regarded as the invention.

Claims (19)

1. A method of treating pelvic conditions, comprising:

making an incision in the vaginal wall;

inserting a graft having at least one wing coupled to a bullet needle through the incision; and

pushing the wing and bullet needle through bodily tissue using a graft placement device.

2. The method ofclaim 1, further comprising pulling the wing back out of incision using the graft placement device.

3. The method ofclaim 1, further comprising releasing the bullet needle and wing from the graft placement device.

4. The method ofclaim 1, further comprising suturing the incision closed.

5. The method ofclaim 1, wherein opening the incision comprises dissection of the paravaginal tissue by pulling back the muscle and flesh.

6. The method ofclaim 1, further comprising loading one of the bullet needles into a graft insertion device such that the remainder of the graft hangs from the graft insertion device, the one of the bullet needles being attached to the terminus of one of the wings.

7. The method ofclaim 1, wherein pushing the wing and bullet needle through anchoring tissue using a graft placement device comprises pushing the wing and bullet needle through any of the commonly accepted apical and lateral support structures.

8. The method ofclaim 1, further comprising trimming away the excess wing material.

9. The method ofclaim 1, further comprising adjusting the graft by pulling the graft and causing the graft to lie substantially flat in its respective compartment.

10. The method ofclaim 1, further comprising cutting the graft into at least two separate pieces.

11. A apparatus for treatment of pelvic conditions, comprising:

a graft having a central body portion and at least one wing extending therefrom, the wing being anchorable to anchoring tissue and having a end portion; and

a bullet needle attached to the end portion.

12. The method ofclaim 11, further comprising a delivery device releasably connectable to the bullet needle and adapted to deploy the graft in a patient.

13. The apparatus ofclaim 11, wherein the graft is made from polypropylene mesh.

14. The apparatus ofclaim 11, wherein the graft is sized and shaped to cover the entire vaginal vault of a patient.

15. The apparatus ofclaim 11, wherein the wing is configured to be anchorable to the sacrospinous ligaments of the patient.

16. The apparatus ofclaim 11, wherein the wing is configured to be anchorable to the arcus tendineus of the patient.

17. The apparatus ofclaim 11, wherein the wing is formed of a material and the bullet needle is formed from the material of the wing.

18. The apparatus ofclaim 11, wherein the bullet needle is connected to the end portion of the wing via a suture.

19. The apparatus ofclaim 11, wherein the graft comprises a mesh having a plurality of open pores bounded by nonwoven polymeric fibers, and wherein the majority of the open pores of the central body portion are larger than the majority of the open pores of the wings.

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